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Impact of Pharmaceutical Care in Diabetics Patients (IPCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01580904
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Universidade Federal do Rio Grande do Norte
Information provided by (Responsible Party):
Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba

Study Description
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Brief Summary:
The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p <0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Behavioral: Intervention: Pharmaceutical Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
No Intervention: control group
Patients will not be followed by the pharmacist.
Experimental: Intervention group

Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.

Intervention: Pharmaceutical Care

 Behavioral: Intervention: Pharmaceutical Care
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice


Outcome Measures
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Primary Outcome Measures :
  1. Glycated Hemoglobin [ Time Frame: Up to 24 weeks ]
    average glycated hemoglobin over 24 weeks

  2. Fasting Glycemia [ Time Frame: Up to 24 weeks ]
    average fasting glycemia over 24 weeks


Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: Up to 24 weeks ]
    average total cholesterol over 24 weeks

  2. LDL Cholesterol [ Time Frame: Up to 24 weeks ]
    average LDL cholesterol over 24 weeks


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion criteria:

  • patients aged 30 years,
  • diagnosed with type 2 diabetes,
  • to make use of oral antidiabetic agents with or without insulin

Exclusion Criteria:

those who had infectious diseases during the research

  • missed three consecutive interviews,
  • suspended the hypoglycemic drug and medical order
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580904


Locations
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Brazil
Universidade Estadual da Paraíba
João Pessoa, Paraíba, Brazil
Sponsors and Collaborators
Universidade Estadual da Paraiba
Universidade Federal do Rio Grande do Norte
Investigators
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Study Director: Ivonete A. Doutorado Universidade Federal do Rio Grande do Norte
More Information
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Additional Information:

Publications:

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Responsible Party: Patrícia Trindade Costa Paulo, Impact of Pharmaceutical Care in Diabetics Patients: Clinical Trial Randomized, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier: NCT01580904    
Other Study ID Numbers: UEParaiba
First Posted: April 19, 2012    Key Record Dates
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba:
Pharmaceutical Care
Diabetics patients
Clinical trial
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases